Regulatory Consulting and Compliance
Guiding You Through the Complexities of Regulatory Approval
Navigating FDA & EMA Regulations for Clinical Trial Success
The clinical trials are strictly regulated by the FDA, EMA and other regulatory bodies to ensure the participants’ safety and the public. They evaluate trial data to decide whether an experimental treatment can be approved for a specific condition. In the US, the FDA’s drug approval process includes the following four stages:
Discovery and Development
This stage includes Pre-clinical Research, IND (Investigational New Drug) Application and Approval.
Clinical Research
There are several phases, namely Phase I to Phase IV of clinical trials that are conducted in order to assess the safety and effectiveness of a new drug or device.
FDA Drug Review
FDA reviews any new drug through the New Drug Application (NDA) that a manufacturer submits to it for its final review, assessment and approval for marketing.
Post-Market Drug Safety monitoring and Risk Assessments
The FDA does post-marketing review through MedWatch to ensure the approved new medicine continues to be safe for public use.
At FDAMap Clinical, we help at all stages of the FDA regulatory approval for a new drug. With over two decades of regulatory experience and more than 100 FDA approvals to our name, we bring unmatched expertise to the table. We specialize in global regulatory consulting and compliance, helping biotech, pharma, and medical device companies navigate the intricate requirements of the regulatory landscape. From early planning to final approval, our team ensures your clinical trials and regulatory submissions are fully aligned with industry standards and regulatory expectations. We have successfully conducted 100s of FDA meeting and all of our regulatory submission have been successful in last 20 years.
We provide end-to-end regulatory support, ensuring compliance and success at every stage:
Regulatory Submissions
- Comprehensive preparation, review, and submission of Investigational New Drug (IND) applications.
- Expert guidance for Biologics License Applications (BLA), New Drug Applications (NDA), and Premarket Approval (PMA) submissions.
- Ongoing communication and negotiations with regulatory authorities to address feedback and expedite approvals.
Good Clinical Practice (GCP) Compliance
- Ensuring all clinical trials adhere to GCP standards, protecting participant safety and data integrity.
- Development and implementation of quality systems to maintain GCP compliance throughout the trial lifecycle.
- Proactive identification and resolution of compliance gaps to reduce regulatory risks.
Inspection Readiness and Audit Support
- Comprehensive readiness assessments to prepare for FDA, EMA, and other regulatory inspections.
- Development of inspection strategies, mock audits, and training for your team to ensure a smooth review process.
- Support during regulatory inspections, including responding to findings and corrective action planning.
Regulatory Milestone Guidance
- Strategic consulting to guide you through key regulatory milestones, from pre-IND meetings to Advisory
- Committee reviews.
- Risk assessment and mitigation plans to address potential regulatory challenges.
- Expert insights to optimize your development pathway and accelerate market approval.
Why Choose FDAMap Clinical?
Partner with a Trusted CRO for Regulatory Excellence and Trial Success
Enhanced Participant Experience
We make trials seamless and supportive for participants, improving engagement and outcomes.
Proven Success
Patient-centric strategies that consistently boost recruitment and retention rates.
Diverse and Inclusive Approach
Our commitment to diversity ensures trials are representative and equitable.
Let Us Simplify the Regulatory Pathway
FDAMap Clinical is your trusted partner in achieving regulatory success. Whether you’re planning your first submission or preparing for a critical inspection, we’re here to provide the expertise and support you need.
Start Your Compliance Journey Today - Contact us to learn more about how our Regulatory Consulting and Compliance services can help bring your product to market successfully.